Background/Aims: A clinical unmet need persists for medications capable of modulating the progression of primary sclerosing cholangitis (PSC). This study aimed to assess the clinical feasibility of HK-660S (beta-lapachone) in PSC. Methods: In this multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 2 trial, participants were assigned in a 2:1 ratio to receive either 100 mg of HK-660S or a placebo twice daily for 12 weeks. The primary outcomes were the reduction in serum alkaline phosphatase (ALP) levels and the percentage of participants showing improvements in PSC severity, as determined by magnetic resonance cholangiopancreatography with the Anali score. Secondary endpoints included changes in liver stiffness and adverse events. Results: The analysis included 21 patients, 15 receiving HK-660S, and six receiving a placebo. Improvements in the Anali score were observed in 13.3% of the HK-660S group, with no improvements in the placebo group. HK-660S treatment resulted in a 15.2% reduction in mean ALP levels, compared to a 6.6% reduction in the placebo group. A stratified ad-hoc analysis based on baseline ALP levels showed a statistically significant response in the HK-660S group among those with ALP levels greater than twice the upper limit of normal, with a 50% responder rate (p=0.05). Additionally, 26.7% of the HK-660S group showed improvements in the enhanced liver fibrosis score, with no improvements in the placebo group. HK-660S was generally well tolerated. Conclusions HK-660S is well tolerated among patients with PSC and may improve bile duct strictures, decrease serum ALP levels, and reduce liver fibrosis (cris.nih.go.kr, Number KCT0006590).

Background/Aims: A clinical unmet need persists for medications capable of modulating the progression of primary sclerosing cholangitis (PSC). This study aimed to assess the clinical feasibility of HK-660S (beta-lapachone) in PSC. Methods: In this multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 2 trial, participants were assigned in a 2:1 ratio to receive either 100 mg of HK-660S or a placebo twice daily for 12 weeks. The primary outcomes were the reduction in serum alkaline phosphatase (ALP) levels and the percentage of participants showing improvements in PSC severity, as determined by magnetic resonance cholangiopancreatography with the Anali score. Secondary endpoints included changes in liver stiffness and adverse events. Results: The analysis included 21 patients, 15 receiving HK-660S, and six receiving a placebo. Improvements in the Anali score were observed in 13.3% of the HK-660S group, with no improvements in the placebo group. HK-660S treatment resulted in a 15.2% reduction in mean ALP levels, compared to a 6.6% reduction in the placebo group. A stratified ad-hoc analysis based on baseline ALP levels showed a statistically significant response in the HK-660S group among those with ALP levels greater than twice the upper limit of normal, with a 50% responder rate (p=0.05). Additionally, 26.7% of the HK-660S group showed improvements in the enhanced liver fibrosis score, with no improvements in the placebo group. HK-660S was generally well tolerated. Conclusions HK-660S is well tolerated among patients with PSC and may improve bile duct strictures, decrease serum ALP levels, and reduce liver fibrosis (cris.nih.go.kr, Number KCT0006590).

Background/Aims: A clinical unmet need persists for medications capable of modulating the progression of primary sclerosing cholangitis (PSC). This study aimed to assess the clinical feasibility of HK-660S (beta-lapachone) in PSC. Methods: In this multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 2 trial, participants were assigned in a 2:1 ratio to receive either 100 mg of HK-660S or a placebo twice daily for 12 weeks. The primary outcomes were the reduction in serum alkaline phosphatase (ALP) levels and the percentage of participants showing improvements in PSC severity, as determined by magnetic resonance cholangiopancreatography with the Anali score. Secondary endpoints included changes in liver stiffness and adverse events. Results: The analysis included 21 patients, 15 receiving HK-660S, and six receiving a placebo. Improvements in the Anali score were observed in 13.3% of the HK-660S group, with no improvements in the placebo group. HK-660S treatment resulted in a 15.2% reduction in mean ALP levels, compared to a 6.6% reduction in the placebo group. A stratified ad-hoc analysis based on baseline ALP levels showed a statistically significant response in the HK-660S group among those with ALP levels greater than twice the upper limit of normal, with a 50% responder rate (p=0.05). Additionally, 26.7% of the HK-660S group showed improvements in the enhanced liver fibrosis score, with no improvements in the placebo group. HK-660S was generally well tolerated. Conclusions HK-660S is well tolerated among patients with PSC and may improve bile duct strictures, decrease serum ALP levels, and reduce liver fibrosis (cris.nih.go.kr, Number KCT0006590).

Background: Chromosomal alterations serve as diagnostic and prognostic markers in acute leukemia. Given the evolving landscape of chromosomal abnormalities in acute leukemia, we previously studied these over two periods. In this study, we investigated the frequency of these abnormalities and clinical trends in acute leukemia in Korea across three time periods. Methods: We retrospectively analyzed data from 1,787 patients with acute leukemia (319 children and 1,468 adults) diagnosed between 2006 and 2020. Conventional cytogenetics, FISH, and multiplex quantitative PCR were used for analysis. The patient groups were divided according to the following three study periods: 2006–2009 (I), 2010–2015 (II), and 2016–2020 (III). Results: Chromosomal aberrations were detected in 92% of patients. The PML::RARA translocation was the most frequent. Over the 15-yr period, chromosomal aberrations showed minimal changes, with specific fusion transcripts being common among patients.ALL was more prevalent in children than in adults and correlated significantly with the ETV6::RUNX1 and RUNX1::RUNX1T1 aberrations. The incidence of ALL increased during the three periods, with PML::RARA remaining common. Conclusions The frequency of chromosomal abnormalities in acute leukemia has changed subtly over time. Notably, the age of onset of adult AML has continuously increased. Our results may help in establishing diagnoses and clinical treatment strategies and developing various molecular diagnostic platforms.

Background and Objectives: We analyzed the data of oropharyngeal squamous cell carcinoma (OPSCC) patients who had transoral surgery with/without adjuvant therapy and experienced recurrence. From the data, the treatment outcomes and prognostic factors of recurrent OPSCC were evaluated, and the predictive factors related to successful salvage treatment were identified.Subjects and Method We used data from patients who were diagnosed with OPSCC and received transoral surgery at the hospital from January 2005 to December 2019. Results: The 5-year survival rate of patients with recurrent OPSCC was 43.9%. The predictors of successful salvage treatment were adjuvant therapy and the p16 status. The 5-year survival rate following salvage treatment for patients who had recurrent OPSCC and also tested p16-positive was 64%; however, it was only 30% for patients who had recurrent OPSCC and tested p16-negative. The 5-year survival rate was 22% for patients who received adjuvant therapy and 64% for those who did not receive it. Conclusion In OPSCC patients who recurred after transoral surgery with/without adjuvant therapy, the salvage treatment success rate was 45%. In recurrent cancer, the HPV status was an important factor associated with successful salvage treatment, as the success rate of salvage treatment was remarkably high in patients who did not receive adjuvant therapy. Thus, we verified that it is crucial to conduct an initial surgery with clear margins and determine the optimal criteria for adjuvant therapy.

Background and Objectives: We analyzed the treatment results and prognostic factors of stage IV oral tongue squamous cell carcinoma (OTSCC) patients and explored the existence of subgroups with distinctive prognoses. In addition, the outcome of salvage therapy was analyzed in recurrent cases, and the survival rates and prognostic factors were investigated.Subjects and Method This study was conducted on patients who were diagnosed with OTSCC and underwent surgery at our hospital between June 2005 and January 2020. A total of 144 patients with stage IV OTSCC was enrolled. Results: A total of 64 recurrences, local (6), regional (21), distant metastasis (33), and locoregional (4), occurred. Seventy-five patients died because of disease progression during the course of study. The 5-year recurrence-free survival rate was 54.5%, and the 5-year disease-specific survival rate was 49.2%. Surgical margins, lymphovascular invasion (LVI), T classification, and lymph nodes (LNs) metastasis exhibited significant correlation with mortality. LVI and advanced T were statistically important factors for predicting distant metastasis. The treatment outcome of the T4N0 patient group without LN metastasis fared the best, while the treatment outcome of the T4N1-3 patient group with advanced T and N findings was the worst. Conclusion The major type of treatment failure in stage IV OTSCC patients was distant metastasis, and the related predictors of distant metastasis were LVI and advanced T. In the stage IV OTSCC patient group, there were subgroups with distinct prognosis according to the combination of T and N classification. The T4N0 group had the best survival rate, and the T4N1-3 group had the worst prognosis.

Background and Objectives: We analyzed the data of oropharyngeal squamous cell carcinoma (OPSCC) patients who had transoral surgery with/without adjuvant therapy and experienced recurrence. From the data, the treatment outcomes and prognostic factors of recurrent OPSCC were evaluated, and the predictive factors related to successful salvage treatment were identified.Subjects and Method We used data from patients who were diagnosed with OPSCC and received transoral surgery at the hospital from January 2005 to December 2019. Results: The 5-year survival rate of patients with recurrent OPSCC was 43.9%. The predictors of successful salvage treatment were adjuvant therapy and the p16 status. The 5-year survival rate following salvage treatment for patients who had recurrent OPSCC and also tested p16-positive was 64%; however, it was only 30% for patients who had recurrent OPSCC and tested p16-negative. The 5-year survival rate was 22% for patients who received adjuvant therapy and 64% for those who did not receive it. Conclusion In OPSCC patients who recurred after transoral surgery with/without adjuvant therapy, the salvage treatment success rate was 45%. In recurrent cancer, the HPV status was an important factor associated with successful salvage treatment, as the success rate of salvage treatment was remarkably high in patients who did not receive adjuvant therapy. Thus, we verified that it is crucial to conduct an initial surgery with clear margins and determine the optimal criteria for adjuvant therapy.

Background and Objectives: We analyzed the treatment results and prognostic factors of stage IV oral tongue squamous cell carcinoma (OTSCC) patients and explored the existence of subgroups with distinctive prognoses. In addition, the outcome of salvage therapy was analyzed in recurrent cases, and the survival rates and prognostic factors were investigated.Subjects and Method This study was conducted on patients who were diagnosed with OTSCC and underwent surgery at our hospital between June 2005 and January 2020. A total of 144 patients with stage IV OTSCC was enrolled. Results: A total of 64 recurrences, local (6), regional (21), distant metastasis (33), and locoregional (4), occurred. Seventy-five patients died because of disease progression during the course of study. The 5-year recurrence-free survival rate was 54.5%, and the 5-year disease-specific survival rate was 49.2%. Surgical margins, lymphovascular invasion (LVI), T classification, and lymph nodes (LNs) metastasis exhibited significant correlation with mortality. LVI and advanced T were statistically important factors for predicting distant metastasis. The treatment outcome of the T4N0 patient group without LN metastasis fared the best, while the treatment outcome of the T4N1-3 patient group with advanced T and N findings was the worst. Conclusion The major type of treatment failure in stage IV OTSCC patients was distant metastasis, and the related predictors of distant metastasis were LVI and advanced T. In the stage IV OTSCC patient group, there were subgroups with distinct prognosis according to the combination of T and N classification. The T4N0 group had the best survival rate, and the T4N1-3 group had the worst prognosis.

Background and Objectives: We analyzed the data of oropharyngeal squamous cell carcinoma (OPSCC) patients who had transoral surgery with/without adjuvant therapy and experienced recurrence. From the data, the treatment outcomes and prognostic factors of recurrent OPSCC were evaluated, and the predictive factors related to successful salvage treatment were identified.Subjects and Method We used data from patients who were diagnosed with OPSCC and received transoral surgery at the hospital from January 2005 to December 2019. Results: The 5-year survival rate of patients with recurrent OPSCC was 43.9%. The predictors of successful salvage treatment were adjuvant therapy and the p16 status. The 5-year survival rate following salvage treatment for patients who had recurrent OPSCC and also tested p16-positive was 64%; however, it was only 30% for patients who had recurrent OPSCC and tested p16-negative. The 5-year survival rate was 22% for patients who received adjuvant therapy and 64% for those who did not receive it. Conclusion In OPSCC patients who recurred after transoral surgery with/without adjuvant therapy, the salvage treatment success rate was 45%. In recurrent cancer, the HPV status was an important factor associated with successful salvage treatment, as the success rate of salvage treatment was remarkably high in patients who did not receive adjuvant therapy. Thus, we verified that it is crucial to conduct an initial surgery with clear margins and determine the optimal criteria for adjuvant therapy.

Background and Objectives: We analyzed the treatment results and prognostic factors of stage IV oral tongue squamous cell carcinoma (OTSCC) patients and explored the existence of subgroups with distinctive prognoses. In addition, the outcome of salvage therapy was analyzed in recurrent cases, and the survival rates and prognostic factors were investigated.Subjects and Method This study was conducted on patients who were diagnosed with OTSCC and underwent surgery at our hospital between June 2005 and January 2020. A total of 144 patients with stage IV OTSCC was enrolled. Results: A total of 64 recurrences, local (6), regional (21), distant metastasis (33), and locoregional (4), occurred. Seventy-five patients died because of disease progression during the course of study. The 5-year recurrence-free survival rate was 54.5%, and the 5-year disease-specific survival rate was 49.2%. Surgical margins, lymphovascular invasion (LVI), T classification, and lymph nodes (LNs) metastasis exhibited significant correlation with mortality. LVI and advanced T were statistically important factors for predicting distant metastasis. The treatment outcome of the T4N0 patient group without LN metastasis fared the best, while the treatment outcome of the T4N1-3 patient group with advanced T and N findings was the worst. Conclusion The major type of treatment failure in stage IV OTSCC patients was distant metastasis, and the related predictors of distant metastasis were LVI and advanced T. In the stage IV OTSCC patient group, there were subgroups with distinct prognosis according to the combination of T and N classification. The T4N0 group had the best survival rate, and the T4N1-3 group had the worst prognosis.